Provide strategic guidance on ISO compliance and ensure alignment with standards. * Monitor and manage the quality action system to ensure timely resolution of issues. * Lead root cause analysis and ...
Provide strategic guidance on ISO compliance and ensure alignment with standards. * Monitor and manage the quality action system to ensure timely resolution of issues. * Lead root cause analysis and ...
Quality Assurance Specialist
$62K - $90K/yr
Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...
Quick apply
Quality Assurance Specialist
$62K - $90K/yr
Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...
Quality Engineer
Menomonee Falls, WI · On-site
$72K - $93K/yr
Act as the primary auditor for internal quality audits in accordance with IATF16949, ISO 9001, and ISO 14001 requirements. * Facilitate, recommend, and implement effective corrective actions by ...
Quick apply
Quality Engineer
Menomonee Falls, WI · On-site
$72K - $93K/yr
Act as the primary auditor for internal quality audits in accordance with IATF16949, ISO 9001, and ISO 14001 requirements. * Facilitate, recommend, and implement effective corrective actions by ...
Quality Engineer - Project Lead
Sturtevant, WI · On-site
$69K - $96K/yr
Develop, assure, and maintain the quality of products and processes, including standard procedures (e.g., ISO 9001:2000, ISO 14000 family of standards), quality audits/review, Taguchi methods, and ...
Quality Engineer - Project Lead
Sturtevant, WI · On-site
$69K - $96K/yr
Develop, assure, and maintain the quality of products and processes, including standard procedures (e.g., ISO 9001:2000, ISO 14000 family of standards), quality audits/review, Taguchi methods, and ...
Quality Assurance Specialist
$62K - $90K/yr
Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...
Quick apply
Quality Assurance Specialist
$62K - $90K/yr
Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...
Ensure contract manufacturer adherence to ZB quality requirements, QSR, and ISO 13485 standards * Provide technical guidance and training to manufacturing personnel * Participate in internal/external ...
Ensure contract manufacturer adherence to ZB quality requirements, QSR, and ISO 13485 standards * Provide technical guidance and training to manufacturing personnel * Participate in internal/external ...
Quality Assurance Specialist
Kenosha, WI · On-site
$65K - $75K/yr
FDA 21 CFR 820, ISO 13485, etc.) * Ensuring auditing and manufacturing documentation is kept up to date. * Review of Intech document to ensure company's processes comply with Quality System (QS ...
Quality Assurance Specialist
Kenosha, WI · On-site
$65K - $75K/yr
FDA 21 CFR 820, ISO 13485, etc.) * Ensuring auditing and manufacturing documentation is kept up to date. * Review of Intech document to ensure company's processes comply with Quality System (QS ...
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The ...
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The ...
Quality Engineer
$76K - $98K/yr
Lead internal and external audits to ensure compliance with applicable quality standards and regulations, supporting ISO 9001 and AS9100D certification activities. * Provide training, guidance, and ...
New
Quick apply
Quality Engineer
$76K - $98K/yr
Lead internal and external audits to ensure compliance with applicable quality standards and regulations, supporting ISO 9001 and AS9100D certification activities. * Provide training, guidance, and ...
New
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The ...
Quality Engineer I
Pleasant Prairie, WI · On-site
$68K - $88K/yr
This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The ...
QA Specialist I - ACM
Madison, WI · On-site
Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...
QA Specialist I - ACM
Madison, WI · On-site
Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...
Quality Engineer 1
Cudahy, WI · On-site
$70K - $91K/yr
Maintain and support the continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 9001 requirements. * Participate in internal and external quality audits and ...
Quick apply
Quality Engineer 1
Cudahy, WI · On-site
$70K - $91K/yr
Maintain and support the continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 9001 requirements. * Participate in internal and external quality audits and ...
Quality Engineer
Lake Geneva, WI · On-site
$85K/hr
Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...
Quick apply
Quality Engineer
Lake Geneva, WI · On-site
$85K/hr
Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...
Quality Manager
Menomonee Falls, WI · On-site
Maintain, improve, and standardize the QMS in alignment with ISO 13485 and customer regulatory requirements * Lead continuous improvement initiatives focused on risk reduction, process capability ...
Quality Manager
Menomonee Falls, WI · On-site
Maintain, improve, and standardize the QMS in alignment with ISO 13485 and customer regulatory requirements * Lead continuous improvement initiatives focused on risk reduction, process capability ...
QA Specialist I - ACM
Madison, WI · On-site
Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...
QA Specialist I - ACM
Madison, WI · On-site
Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...
Quality Engineer
Lake Geneva, WI · On-site
$85K/hr
Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...
Quick apply
Quality Engineer
Lake Geneva, WI · On-site
$85K/hr
Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...
WI · On-site
$120 - $140/hr
Oversee ISO 9001:2015 certification activities, including audits and corrective actions. * Maintain calibration requirements for all tools and gauges. * Share best practices across Toro locations and ...
WI · On-site
$120 - $140/hr
Oversee ISO 9001:2015 certification activities, including audits and corrective actions. * Maintain calibration requirements for all tools and gauges. * Share best practices across Toro locations and ...
Quality Engineer
Port Washington, WI · On-site
$68K - $87K/yr
Proven experience with ISO and IATF standards and quality management systems. * Proven experience with formal auditing * Strong knowledge and application of Statistical Process Control (SPC) and ...
Quick apply
Quality Engineer
Port Washington, WI · On-site
$68K - $87K/yr
Proven experience with ISO and IATF standards and quality management systems. * Proven experience with formal auditing * Strong knowledge and application of Statistical Process Control (SPC) and ...
Corporate Quality Engineer
Slinger, WI · On-site
$73K - $95K/yr
This role partners with plant leadership, suppliers, and customers to drive continuous improvement, enhance process capability, reduce quality costs, and ensure compliance with ISO and customer ...
New
Corporate Quality Engineer
Slinger, WI · On-site
$73K - $95K/yr
This role partners with plant leadership, suppliers, and customers to drive continuous improvement, enhance process capability, reduce quality costs, and ensure compliance with ISO and customer ...
New
Corporate Quality Engineer
Slinger, WI · On-site
$70K - $80K/yr
This role partners with plant leadership, suppliers, and customers to drive continuous improvement, enhance process capability, reduce quality costs, and ensure compliance with ISO and customer ...
Corporate Quality Engineer
Slinger, WI · On-site
$70K - $80K/yr
This role partners with plant leadership, suppliers, and customers to drive continuous improvement, enhance process capability, reduce quality costs, and ensure compliance with ISO and customer ...
Iso 11607 information
What is the difference between Iso 11607 vs Packaging Technician?
| Aspect | Iso 11607 | Packaging Technician |
|---|---|---|
| Certifications | Standards for sterile packaging | Often certified in packaging processes |
| Work Environment | Manufacturing and sterile packaging facilities | Packaging lines, production areas |
| Industry Usage | Medical device and pharmaceutical packaging | Medical device, pharmaceutical, and consumer goods |
| Primary Focus | Ensuring packaging meets sterilization and safety standards | Assembling, inspecting, and packaging products |
While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.
What challenges do professionals face when working with ISO 11607 compliance?
What is ISO 11607?
What skills and qualifications are needed to work with ISO 11607?
Full-time
Re-posted 18 days ago
Bassett Mechanical rating
8.7
Based on 5 frontline employees who took The Breakroom Quiz
27th of 278 rated repair and maintenance companies
Job description
Bassett Mechanical is a 3rd generation family-owned company that provides custom-built industrial refrigeration, HVAC, plumbing, metal fabricating and preventative maintenance service solutions to customers throughout the United States and the world. It is not only a great place to grow and thrive in your career. It is a place to truly belong. As a member of the Bassett Mechanical Team, you'll enjoy a competitive compensation and benefits package and many professional growth opportunities. From the moment you're hired, to the day you retire, you're a part of our Bassett Mechanical Team.
Position Purpose
The Quality Assurance and Regulatory Compliance Specialist oversees the company’s quality systems and regulatory compliance activities, ensures alignment with ISO standards and applicable requirements, maintains and administers document control systems, and works collaboratively across the organization.
This role plays a critical part in identifying quality issues, coordinating internal and external audits, managing corrective actions, and supporting compliance readiness. The role also emphasizes documentation, training, and sustained adherence to regulatory and quality requirements across the organization.
Position Responsibilities
- Quality Assurance
- Provide strategic guidance on ISO compliance and ensure alignment with standards.
- Monitor and manage the quality action system to ensure timely resolution of issues.
- Lead root cause analysis and develop corrective actions for non-conformities.
- Analyze quality trends and collaborate with teams to implement preventive measures.
- Internal and External Audit Leadership
- Coordinate scheduling and preparation for ISO and other external customer/regulatory audits.
- Lead the internal audit team and perform internal audits.
- Develop and maintain audit documentation and train internal auditors.
- Track and oversee the resolution of audit findings to ensure compliance.
- Documentation
- Maintain and oversee document control systems, ensuring accuracy and accessibility of records.
- Manage document change requests and approval workflows.
- Create and update quality documentation, including procedures and work instructions.
- Regulatory Compliance
- Monitor regulatory requirements and internal obligations to ensure ongoing compliance across applicable quality systems.
- Support regulatory inspections, customer requirements, and compliance assessments by coordinating documentation and evidence.
- Partner with internal teams to address compliance gaps, implement corrective actions, and maintain readiness for audits and reviews.
- Promote awareness of regulatory obligations through training, documentation updates, and standardized compliance practices.
- Collaboration and Reporting
- Partner with cross-functional teams to address quality issues and share findings.
- Prepare and present reports on quality trends, audit outcomes, compliance status, and corrective actions to leadership.
- Act as a liaison between departments to align quality goals with organizational objectives.
- Support and maintain a safe and Lean work environment.
- Other duties as assigned.
Summary of Skills, Knowledge and Abilities
- Bachelor’s degree in Quality Management, Regulatory Affairs, or a related field (preferred) or equivalent experience.
- 3+ years of experience in quality assurance, regulatory compliance, auditing, or related roles.
- Proven experience with ISO standards (e.g., ISO 9001) and internal auditing.
- Strong understanding of quality management systems, regulatory requirements, and compliance methodologies.
- Demonstrated leadership in coordinating audits and testing processes.
- Proficiency in Microsoft Office Suite and quality management software.
- Exceptional organizational, analytical, and problem-solving skills.
- Effective communication and collaboration abilities across diverse teams.
- Proactive and results-oriented with a strong compliance and accountability mindset.
- Flexible and adaptable to dynamic organizational needs.
- Committed to professional growth and staying current with industry trends
Direct Reports
- None
What Bassett Mechanical employees say
Pay
Hours and flexibility
Workplace
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About Bassett Mechanical
Sourced by ZipRecruiter
Industry
Industrial machinery manufacturing
Company size
201 - 500 Employees
Headquarters location
Kaukauna, WI, US
Year founded
1936